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FDA 510(k)

FRIENDLY LIGHT ER:YAG PULSED LASER

K-Number: K000023 · 2000-11-06

ApplicantInnotech USA, Inc.
Decision Date2000-11-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FRIENDLY LIGHT ER:YAG PULSED LASER is the device name listed in this FDA 510(k) record. The listed applicant is Innotech USA, Inc.. It received FDA 510(k) clearance on 2000-11-06 under 510(k) number K000023. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRIENDLY LIGHT ER:YAG PULSED LASER?

FRIENDLY LIGHT ER:YAG PULSED LASER is a medical device that received FDA 510(k) clearance on 2000-11-06. The listed applicant is Innotech USA, Inc.. The 510(k) number is K000023.

When did FRIENDLY LIGHT ER:YAG PULSED LASER receive FDA 510(k) clearance?

FRIENDLY LIGHT ER:YAG PULSED LASER received FDA 510(k) clearance on 2000-11-06, under 510(k) number K000023.

Who is the listed applicant for FRIENDLY LIGHT ER:YAG PULSED LASER?

The FDA 510(k) record lists Innotech USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRIENDLY LIGHT ER:YAG PULSED LASER?

The FDA product code for FRIENDLY LIGHT ER:YAG PULSED LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Innotech USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K033251THE FRIENDLYLIGHT ND: YAG LASERSK013021LIGHTLANCE LASER SKIN PERFORATOR

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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